Medical device for wound closure and method of use

ABSTRACT

A medical device for wound closure, e.g., repairing perforations and tissue wall defects. The medical device has a barbed elongate body and an outer member. The medical device may further include a foam structure. The medical device may also include an inner member which may be a tissue scaffold. A method for closing tissue is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/511,462, filed on Jul. 29, 2009, now U.S. Pat. No. 9,943,302,which claims priority to, and the benefit of, U.S. Provisional PatentApplication Ser. No. 61/088,145, filed on Aug. 12, 2008, the entirecontents of each of which are hereby incorporated by reference.

BACKGROUND Technical Field

The present disclosure relates to a medical device and more particularlya wound closure device for repairing perforations in tissue and sealinga tissue wall.

Background of Related Art

A variety of surgical procedures, for example, laparoscopic procedures,are performed through an access port, during which the access portpunctures the tissue to provide access to the surgical site. Punctures,if left untreated for a period of time, may allow for fluid passage fromone tissue/organ to another. Fluid passage between certain tissues maycontribute to undesirable complications such as infection.

Currently, wound closure devices such as sutures are used to closevarious layers of tissue post-surgery. Suturing a patient after removalof an access device may be cumbersome, while accumulating additionalcosts to the patient such as increased time spent in the operating room.

It would be advantageous to provide a device which enables improved,e.g., faster, closure of tissue punctures or tissue perforations forcertain procedures.

SUMMARY

A medical device for wound closure is described herein which providesfor improved wound closure. In one embodiment, the medical deviceincludes an elongate body having a plurality of barbs extending from asurface thereof, and an inner member and outer member, each moveablypositioned along the elongate body.

In one embodiment, the inner member and outer member are each spacedfrom a distal portion of the elongate body. In use, the inner member ispreferably moveably positionable between a tissue wall and the outermember. In certain embodiments, the inner member is a tissue scaffold.The outer member is preferably relatively rigid as compared to the innermember. The outer member may also serve as a tissue scaffold.

The medical device may also include a foam structure attached to thedistal portion of the elongate body. Preferably, the foam structure isconfigured to change dimension from a first compressed shape fordelivery to second expanded shape for placement. The foam structure mayalso be shaped so as to limit movement proximally through a tissue wall.In certain embodiments, the foam structure is a closed cell foam.

The elongate body preferably also includes a plurality of barbs whichare oriented so as to enable the outer member to move distally along theelongate body while limiting proximal movement of the outer member.

Another embodiment of a medical device for wound closure disclosedherein includes an elongate body having a distal portion and a proximalportion, and a plurality of barbs extending from a surface thereof. Themedical device further includes a foam structure attached to the distalportion of the elongate body and an outer member moveably positioned onthe elongate body. In some embodiments, the medical device may alsoinclude a tissue scaffold moveably positioned on the elongate body. Insitu, the tissue scaffold may be at least partially positioned in atissue perforation.

Tissue scaffolds of the present disclosure may be selected from thegroup consisting of proteins, polysaccharides, polynucleotides, poly(α-hydroxy esters), poly (hydroxy alkanoates), poly (ortho esters),polyurethanes, polylactones, poly (amino acids), and combinationsthereof.

A method of closing tissue is also disclosed, the method comprising thesteps of positioning a medical device through a tissue wall such that afoam structure at a distal end of the medical device is adjacent aninner surface of the tissue; and, advancing an outer member distallyover barbs on a surface of the elongate body so as to secure the medicaldevice in situ.

An alternate method of closing tissue is disclosed, the methodcomprising the steps of inserting a medical device through a tissuewall, at least a portion of the medical device being contained within asleeve; removing the sleeve such that a foam structure at a distal endof the medical device is positioned adjacent an inner surface of thetissue; and, advancing an outer member distally over barbs on a surfaceof the elongate body so as to secure the medical device in situ.

BRIEF DESCRIPTION OF DRAWINGS

Various preferred embodiments of the wound closure devices are describedherein with reference to the drawings, in which:

FIG. 1 is a perspective view of one embodiment of a wound closure devicein accordance with the present disclosure;

FIGS. 2A-2D are side views of the device of FIG. 1, with portions oftissue removed, showing the steps of placement of the device;

FIG. 3 is an alternate embodiment of a wound closure device inaccordance with the present disclosure;

FIG. 4 is a side view of the device of FIG. 3, with portions of tissueremoved, showing the device in tissue;

FIG. 5A is a side view of the device of FIG. 3 in a first, compressedshape; and,

FIG. 5B is a side view of the device of FIG. 3 in tissue, with portionsof tissue removed, in a second, expanded shape.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure is directed to a medical, e.g., wound closure,device. The wound closure device includes an elongate body having aplurality of barbs extending from the surface. The device also includesan inner member and an outer member, each moveably positioned on aproximal portion of the elongate body. In certain embodiments, the woundclosure device further includes a foam structure attached to a distalportion of the elongate body. In some embodiments, the inner member orthe outer member may function as a tissue scaffold moveably positionedon the elongate body.

In the description that follows, the term “proximal” as used herein,means the portion of the device which is nearer to the user, while theterm “distal” refers to the portion of the device which is further awayfrom the user. The term “tissue” as defined herein means various skinlayers, muscles, tendons, ligaments, nerves, fat, fascia, bone anddifferent organs.

A wound closure device according to one embodiment of the presentdisclosure is illustrated in FIG. 1. The wound closure device 2comprises an elongate body 4 which includes a plurality of barbs 7disposed along a surface of the elongate body 4. The elongate body 4 isgenerally cylindrical in shape and may have a generally circularcross-sectional area, although other shapes and cross-sectional areasare envisioned. In particular, the elongate body 4 is in the form of asuture and is comprised of a biodegradable polymeric material. A distalportion 4 a of the elongate body 4 is connected to a foam structure 6.In particular, the elongate body 4 is centrally connected to arelatively flat surface 6 b of the foam structure 6. Although showncentrally located, the elongate body 4 could also be attachedoff-center. The elongate body 4 may be connected to the foam structure 6using various methods within the purview of those skilled in the artincluding, but not limited to, molding, over molding, adhesives andglues (e.g., cyanoacrylates), mechanical connections, male and femalelocking mechanisms, and the like.

As illustrated in FIG. 1, the foam structure 6 is generally conical orhemispherical in shape. A distal portion 6 a of the foam structure 6 isgenerally arcuate in shape and once inserted through a tissue wall, thefoam structure 6 is relatively convex with respect to a tissue wall. Aproximal portion 6 b of the foam structure 6 is generally flat and, inuse, is positioned adjacent a tissue wall so as to seal a tissueperforation and prevent fluids from passing through a tissue wall ortissue plane. It should be noted that although the foam structure isillustrated as generally conical in shape, this disclosure is notlimited to conical-shaped foam structures and other shapes arecontemplated. The foam structure is large enough, for example, to extendover a tissue perforation created by an access device (e.g., endoluminaldevice), sealing the tissue wall and limiting fluid passage from a firstside of a tissue wall to a second side of a tissue wall. It should alsobe noted that certain embodiments may not include a foam structure.

Foams of the present disclosure may be compressible and are capable ofundergoing a change in shape. The foam structure may be of a configuredto change shape from a first compressed shape when inserted in tissuefor delivery to a second, expanded shape for placement. Upon penetrationof a tissue wall, the foam structure may expand to seal a tissue defect.Foam structures of the present disclosure also are shaped so as to limitmovement proximally through a tissue wall, once inserted. The foamstructure may be constructed of a material which expands from heat orfluid (polymer hydrogels) contact; alternately, the foam structure maybe mechanically compressed through use of a member such as a sleevee.g., introducer, wherein upon removal of the sleeve, the foam expands.Other members including the outer member and the inner member may alsobe compressible foams which change shape from a first, smaller shape, toa second, larger shape.

Foams may have an open cell structure where the pores are connected toeach other, forming an interconnected network. Conversely, foams of thepresent disclosure may be closed cell foams where the pores are notinterconnected. Closed cell foams are generally denser and have a highercompressive strength. In certain preferred embodiments, the foamstructure of the present disclosure is a closed cell foam.

Tissue damage or tissue voids may have the potential to form adhesionsduring certain healing periods. Foam structures of the presentdisclosure may be chemically tailored to have anti-adhesive properties,which may assist in preventing adjacent tissue walls from adheringtogether, preventing adhesions at a wound site. In various embodiments,the foam structures may be made of anti-adhesive materials.Alternatively, the foam structures may be coated with anti-adhesivematerials.

Referring back to FIG. 1, the elongate body 4 has an inner member 8 andan outer member 10 mounted thereon. The inner member 8 and the outermember 10 are spaced from the distal portion 4 a of the elongate body 4.In a preferred embodiment, the inner member 8 and the outer member 10are located on the proximal portion 4 b of the elongate body.Alternately, when the elongate body is longer in length, the innermember and outer member may be moveably mounted on a central portion ofthe elongate body. Each of the inner member 8 and outer member 10 has anopening extending therethrough and is moveably positioned on theelongate body 4. In situ, the inner member 8 is positioned between atissue wall (not shown) and the outer member 10. Both the inner member 8and the outer member 10 are generally shaped like a disc, although othershapes are envisioned. In some embodiments, the inner member 8 may beconfigured to fill a surface void or tissue defect. The outer member 10is generally rigid as compared to the inner member 8 so as to affectmovement of the inner member 8. In a preferred embodiment, the innermember 8 is comprised of an absorbable polymer such as collagen. Theinner member 8 may be in the form of a sheet or a porous material suchas foam. The outer member 10 may of any solid or dense porous materialwhich is rigid, so as to impart movement on the inner member 8 as it isadvanced distally along an elongate body 4.

In certain embodiments, at least the inner member 8 may provide a tissuescaffold for cellular infiltration and tissue ingrowth. It is alsoenvisioned that in alternate embodiments, the outer member 10 mayprovide a scaffold for tissue ingrowth. The tissue scaffold is porousand provides a temporary scaffold/substrate for cell adherence. Tissuescaffolds may be tailored to closely match the mechanical properties ofthe surrounding tissue intended for regeneration. For example, when thewound closure device is used to close dermal tissue, the scaffold may bemechanically tuned to complement dermal tissue.

In preferred embodiments, the tissue scaffold comprises degradablematerials including those listed below, and in certain preferredembodiments the tissue scaffold is collagen. The scaffold degradationprofile can be tailored to allow cells to proliferate while the tissuescaffold degrades over time. One skilled in the art can alter thedegradation profile of a tissue scaffold by changing various parametersincluding but not limited to polymer composition and chemistry, density,morphology, molecular weight, size, porosity and pore size, wettabilityand processing parameters.

As illustrated in FIG. 1, the elongate body 4 further includes aplurality of barbs 7 which may be aligned to enable the wound closuredevice 2 to move through tissue in one direction while resistingmovement through tissue in a generally opposite direction. That is, thebarbs 7, extending from the surface of the elongate body 4, permitmovement of inner member 8 and outer member 10 in a distal directionwhile resisting movement of the inner member 8 and outer member 10 in aproximal direction. Additionally, the barbs 7 prevent movement of thefoam structure 6 towards a proximal portion of the device. Once the foamstructure 6 of the device 2 is positioned adjacent a tissue wall, theouter member 10 is advanced in a distal direction along the elongatebody 4, thereby moving the inner member 8 in a distal direction (withthe barbs preventing proximal movement). Once the inner member 8 andouter member 10 are fully distally advanced e.g., contacting a tissuewall, the barbs 7 prevent proximal movement of the inner and outermembers (8 and 10), thereby fixating the device 2 against the tissuewall (not shown).

The term “barbs” as used herein encompasses various projections from thesurface of an elongate body. Preferably the barbs are formed integrallywith the elongate body 4. Barbs extending from the outer surface of theelongate body 4 include but are not limited to projections such asthreads, anchors, and teeth. In some embodiments, the barbs areyieldable toward the elongate body 4 of the wound closure device. Thebarbs can be arranged in any suitable pattern, for example helical,linear, or randomly spaced. The number, configuration, spacing andsurface area of the barbs can vary depending upon the tissue type inwhich the device is used, as well as the composition and geometry of thematerial utilized to form the device. For example, if the wound closuredevice is intended to be used in fatty tissue, which is relatively soft,the barbs may be longer and spaced further apart to enable it to gripthe soft tissue. The barbs can be arranged in various directions atvarious angles. In some embodiments, the wound closure device mayinclude a staggered arrangement of large or small barbs.

The shape and/or surface area of the barbs can also vary. For example,fuller-tipped barbs can be made of varying sizes designed for specificsurgical applications. In certain applications, such as when closing anaccess port site and the surgeon is working with fat and relatively softtissues, larger barbs may be desired, whereas smaller barbs may be moresuitable for different procedures with collagen-dense tissues. In someembodiments, a combination of large and small barbs within the samestructure may be beneficial, for example when a wound closure device isused in tissue repair with differing layer structures. Use of thecombination of large and small barbs on the same device, wherein barbsizes are customized for each tissue layer will ensure maximum holdingstrength of the device in situ.

FIGS. 2A and 2B illustrate according to one embodiment, a method bywhich the wound closure device of FIG. 1 may be positioned in tissue.Note, portions of the tissue are removed for clarity. In FIG. 2A, adevice 2 is shown in a first position where a foam structure 6 haspartially penetrated a tissue wall 30. The device may be inserted intotissue and a distal portion of the device 2 may be inserted through atissue wall 30 with or without the use of an inserter (not shown). Oncethe device 2 is completely inserted and the foam structure 6 has fullypenetrated the tissue wall 30, the proximal portion 6 b of the foamstructure 6 may be rotated (by the user or an insertion device) forpositioning against the tissue wall 30 (FIG. 2B). The proximal portion 6b of the foam structure 6, which may be generally flat, is positionedadjacent a tissue wall 30 so as to seal a puncture wound and preventfluids from passing through the tissue wall or tissue plane. It shouldbe noted that the foam structure 6 may be inserted in a position so asto minimize tissue contact during delivery. As shown in FIG. 1, the foamstructure 6 is inserted at an angle and rotated or turned into positionagainst a tissue wall 30; in other embodiments, an inserter may to usedwhich enables the foam structure 6 to be inserted in a compressedposition so as to minimize tissue contact during delivery.

In the next step, an outer member 10 is advanced in a distal directionas indicated by an arrow in FIG. 2C. As previously described, the outermember 10 may be rigid as compared to an inner member 8, and itsmovement imparts movement of the inner member 8. That is, the outermember 10 is advanced towards the inner member 8 and once in contact,the outer member 10 and the inner member 8 move together over the barbedsurface 4 in a distal direction so as to secure the device 2 in tissue(FIG. 2D). In a final position, the inner member 8 is adjacent a tissuesurface 31, applying pressure to the tissue surface 31 so as to limitmovement of the device 2. As the inner member 8 and the outer member 10are advanced over the barbed surface 4, the barbs 7 inhibit movement ofthe inner and outer members (8, 10) in a proximal direction. The barbs 7may also prevent the foam structure 6 from reversible movement afterpenetration of the tissue wall 30. It should be noted that althoughFIGS. 2A-2D illustrate the embodiment described in FIG. 1, otherembodiments described herein will be placed in tissue in a similarmanner.

Another embodiment of a wound closure device 40 is shown in FIG. 3. Anelongate body 44 is connected at a distal portion 44 a to a foamstructure 42 the elongate body 44 has an outer member 48 mountedthereon, spaced from a distal portion 44 a of the elongate body. Thefoam structure 42 may be generally conical or hemispherical in shape,having a generally flat proximal portion 42 b and a curved or somewhatpointed distal portion 42 a. The foam structure 42 is circular incross-sectional area, taken along line A-A, although other shapes areenvisioned. The foam structure 42 may be centrally attached to a barbedelongate body 44, or could alternatively be attached off-center. Thebarbs 46 function in a similar manner as described above and may havevarious lengths and may be disposed at different angles relative to asurface of the elongate body 44. The outer member 48 has an openingextending therethrough and is rigid enough to move in a distal directionover the barbed elongate body 44. The outer member 48 as shown isfunnel-shaped such that a proximal portion 48 b has a largercross-sectional area, which narrows toward a distal portion 48 a. Insitu, the distal portion 48 a may partially penetrate a tissue plane, asillustrated in FIG. 4. The funnel shape of the outer member 48 mayassist in further sealing of a tissue defect which may be created by anaccess device such as an endoscopic device used for Natural OrificeTransluminal Endoscopic Surgery (N.O.T.E.S.). In certain embodiments,the outer member may further include an active agent such as a hemostat.

Wound closure devices of the present disclosure may be inserted with theassistance of an introducer (insertion device). FIG. 5A illustrates theembodiment of FIGS. 3 and 4 by way of example, it being understood thatother embodiments of a wound closure device as described herein may alsobe compressed by a sleeve for insertion into tissue. The sleeve 52 maybe employed to retain the foam structure 42 in a first, compressed shapefor insertion/delivery. The sleeve 52 also extends over the elongatebody 44 and outer member 48. Upon penetrating a tissue wall 60 (FIG.5B), the sleeve 52 may be removed (retracted in the direction of thearrow), allowing the foam structure 42 to expand to a second largershape, extending over a tissue defect 60 a, for placement. Once thesleeve is removed, the outer member 48 may be advanced in a distaldirection, securing the device in place. The sleeve may also keep othermembers of the device, e.g., inner members and tissue scaffolds, in acompressed position for insertion into a body cavity.

Materials used to construct the wound closure devices of the presentdisclosure may include biodegradable materials which may be syntheticand natural materials. The term “biodegradable” as used herein refers tomaterials which decompose, or lose structural integrity under bodyconditions (e.g., enzymatic degradation or hydrolysis). Suitablesynthetic biodegradable materials may include, but are not limited to,polymers such as those made from lactide, glycolide, caprolactone,valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylenecarbonate, and the like), dioxanones (e.g., 1,4-dioxanone),δ-valerolactone, 1,dioxepanones (e.g., 1,4-dioxepan-2-one and1,5-dioxepan-2-one), ethylene glycol, ethylene oxide, esteramides,γ-hydroxyvalerate, β-hydroxypropionate, alpha-hydroxy acid,hydroxybuterates, poly (ortho esters), hydroxy alkanoates, tyrosinecarbonates, polyimide carbonates, polyimino carbonates such as poly(bisphenol A-iminocarbonate) and poly (hydroquinone-iminocarbonate),polyurethanes, polyanhydrides, polymer drugs (e.g., polydiflunisol,polyaspirin, and protein therapeutics) and copolymers and combinationsthereof.

In certain preferred embodiments, the foam structure comprises amaterial which contains an aliphatic diacid linking two dihydroxycompounds. The dihydroxy compounds which may be utilized include, butare not limited to, polyols including polyalkylene oxides, polyvinylalcohols, and the like. In some embodiments, the dihydroxy compounds canbe a polyalkylene oxide such as polyethylene oxide (“PEO”),polypropylene oxide (“PPO”), block or random copolymers of polyethyleneoxide (PEO) and polypropylene oxide (PPO). Suitable aliphatic diacidswhich may be utilized in forming the foams include, for example,aliphatic diacids having from about 2 to about 8 carbon atoms suitablediacids include, but are not limited to sebacic acid, azelaic acid,suberic acid, pimelic acid, adipic acid, glutaric acid, succinic acid,malonic acid, oxalic acid and combinations thereof.

In one embodiment, a polyethylene glycol (“PEG”) may be utilized as thedihydroxy compound as disclosed in U.S. Patent Application PublicationNo. 20060253094, the entire disclosure of which is incorporated byreference herein. It may be desirable to utilize a PEG with a molecularweight ranging from about 200 to about 1000, typically from about 400 toabout 900. Suitable PEGs are commercially available from a variety ofsources under the designations PEG 200, PEG 400, PEG 600 and PEG 900.

Suitable natural biodegradable polymers may include, but are not limitedto, collagen, poly (amino acids), polysaccharides such as cellulose,dextran, chitin, and glycosaminoglycans, hyaluronic acid, gut,copolymers and combinations thereof. In preferred embodiments, collagenis used to construct the inner member of the medical device. Collagen asused herein includes natural collagen such as animal derived collagen,or synthetic collagen such as human or bacterial recombinant collagen.

The collagen can be modified by using any method known to those skilledin the art to provide pendant portions of the collagen with moietieswhich are capable of covalently bonding with the reactive chemicalgroups of a glycosaminoglycan. Examples of such pendant moieties includealdehydes, sulfones, vinylsulfones, isocyanates, and acid anhydrides. Inaddition, electrophilic groups such as —CO₂N(COCH₂)₂, —CO₂N(COCH₂)₂,—CO₂H, —CHO, —CHOCH₂, —N═C═O, —SO₂CH═CH₂, —N(COCH)₂, —S—S—(C₅H₄N) mayalso be added to pendant chains of the collagen to allow covalentbonding to occur with the glycosaminoglycans.

In some embodiments, the collagen may be modified through the additionof an oxidizing agent. Contacting collagen with an oxidizing agentcreates oxidative cleavage along portions of the collagen therebycreating pendant aldehyde groups capable of reacting with theglycosaminoglycans. The oxidizing agent may be, for example, iodine,peroxide, periodic acid, hydrogen peroxide, a periodate, a compoundcontaining periodate, sodium periodate, a diisocyanate compound, ahalogen, a compound containing halogen, n-bromosuccinimide, apermanganate, a compound containing permanganate, ozone, a compoundcontaining ozone, chromic acid, sulfuryl chloride, a sulfoxide, aselenoxide, an oxidizing enzyme (oxidase) and combinations thereof. Incertain embodiments, the oxidizing agent is periodic acid.

In certain applications it may be preferred to have certain members ofthe wound closure device comprise non-degradable materials. For example,in applications where a wound closure device is used for dermal closure,it may be beneficial for the outer member to be non-degradable. Anon-degradable material may be better suited for an externalenvironment, or may provide better resistance against skin flora,compared to certain biodegradable materials.

Suitable non-biodegradable materials may be used to construct the woundclosure device including, but not limited to, fluorinated polymers(e.g., fluoroethylenes, propylenes, fluoroPEGs), polyolefins such aspolyethylene, polyesters such as poly ethylene terepththalate (PET),nylons, polyamides, polyurethanes, silicones, ultra high molecularweight polyethylene (UHMWPE), polybutesters, polyethylene glycol,polyaryletherketone, copolymers and combinations thereof. Additionally,non-biodegradable polymers and monomers may be combined with each otherand may also be combined with various biodegradable polymers andmonomers to create a composite device.

In certain embodiments, medical devices according to the presentdisclosure may be constructed at least in part using shape memorypolymers. Suitable polymers used to prepare hard and soft segments ofshape memory polymers may include, but are not limited to,polycaprolactone, dioxanone, lactide, glycolide, polyacrylates,polyamides, polysiloxanes, polyurethanes, polyether amides,polyurethane/ureas, polyether esters, and urethane/butadiene copolymersand combinations thereof. For example, the foam structure may compriseshape memory materials which expand the foam upon reaching bodytemperature, sealing an inner tissue wall.

In some embodiments, the medical device may comprise metals (e.g., steelor titanium), metal alloys and the like. In alternate embodiments, theelongate body or outer member may comprise degradable metals such asdegradable magnesium.

Suitable materials of the present disclosure can be processed by methodswithin the purview of those skilled in the art including, but notlimited to extrusion, injection molding, compression molding, blowmolding, film blowing, thermoforming, calendaring, spinning, and filmcasting.

More specifically, foams of the present disclosure can be manufacturedusing various processes within the purview of those skilled in the art.For example, foams can be manufactured though standard lyophilization(freeze drying) techniques, solvent casting and particulate leaching,compression molding, phase separation, gas foaming (e.g., internalblowing agents such as CO₂), or through the use of a porogen (e.g., saltparticles). In certain embodiments, foams which are used as tissuescaffolds can also be created through computer aided design techniquesincluding solid freeform fabrication (SFF).

Additionally, any part of the device may include biologically acceptableadditives such as plasticizers, antioxidants, dyes, image-enhancingagents, dilutants, bioactive agents such as pharmaceutical and medicinalagents, and combinations thereof which can be coated on the woundclosure device or impregnated within the resin or polymer.

Medicinal agents which may be incorporated into the wound closure devicemay include, but are not limited to, antimicrobial agents, anti-virals,anti-fungals, and the like. Antimicrobial agents as used herein isdefined by an agent which by itself or through assisting the body(immune system) helps the body destroy or resist microorganisms whichmay be pathogenic (disease causing). The term “antimicrobial agent”includes, e.g., antibiotics, quorum sensing blockers, surfactants, metalions, antimicrobial proteins and peptides, antimicrobialpolysaccharides, antiseptics, disinfectants, anti-virals, anti-fungals,quorum sensing blockers, and combinations thereof.

Examples of suitable antiseptics and disinfectants which may be combinedwith the present disclosure include hexachlorophene; cationic biguanideslike chlorohexadine and cyclohexidine; iodine and iodophores likepovidone-iodine; halo-substituted phenolic compounds like PCMX (e.g.,p-chloro-m-xylenon) and triclosan (e.g.,2,4,4′-trichloro-2′hydroxy-diphenylether); furan medical preparationslike nitrofurantoin and nitrofurazone; methanamine; aldehydes likegluteraldehyde and formaldehyde; alcohols; combinations thereof, and thelike. In some embodiments, at least one of the antimicrobial agents maybe an antiseptic, such as triclosan.

Classes of antibiotics that can be combined with the present disclosureinclude tetracyclines like minocycline; rifamycins like rifampin;macrolides like erythromycin; penicillins like nafcillin; cephalosporinslike cefazolon; beta-lactam antibiotics like imipenen and aztreonam;aminoglycosides like gentamicin and TOBRAMYCIN®; chloramphenicol;sulfonamides like sulfamethoxazole; glycopeptides like vancomycin;quilones like ciproflaxin; fusidic acid; trimethoprim; metronidazole;clindamycin; mupirocin; polyenes like amphotericin B; azoles likefluconazole; and beta-lactam inhibitors like sublactam. Otherantimicrobials which may be added include, for example antimicrobialpeptides and/or proteins; antimicrobial polysaccharides; quorum sensingblockers (e.g., brominated furanones); anti-virals; metal ions such asionic silver and ionic silver glass; surfactants; chemotherapeutic drug;telomerase inhibitors; other cyclic monomers including 5-cyclicmonomers; mitoxantrone; and the like.

In some embodiments, suitable bioactive agents which may be used includecolorants, dyes, preservatives, protein and peptide preparations,protein therapeutics, polysaccharides such as hyaluronic acid, lectins,lipids, probiotics, angiogenic agents, anti-thrombotics, anti-clottingagents, clotting agents, analgesics, anesthetics, wound repair agents,chemotherapeutics, biologics, anti-inflammatory agents,anti-proliferatives, diagnostic agents, antipyretic, antiphlogistic andanalgesic agents, vasodilators, antihypertensive and antiarrhythmicagents, hypotensive agents, antitussive agents, antineoplastics, localanesthetics, hormone preparations, antiasthmatic and antiallergicagents, antihistaminics, anticoagulants, antispasmodics, cerebralcirculation and metabolism improvers, antidepressant and antianxietyagents, vitamin D preparations, hypoglycemic agents, antiulcer agents,hypnotics, antibiotics, antifungal agents, sedative agents,bronchodilator agents, antiviral agents, dysuric agents, brominated orhalogenated furanones, and the like. In embodiments, polymer drugs,e.g., polymeric forms of such compounds for example, polymericantibiotics, polymeric antiseptics, polymeric chemotherapeutics,polymeric anti-proliferatives, polymeric antiseptics, polymericnon-steroidal anti-inflammatory drugs (NSAIDS), and the like may beutilized and combinations thereof.

In certain embodiments, medical devices of the present disclosure maycontain suitable medicinal agents such as viruses and cells; peptides;polypeptides and proteins, analogs, muteins, and active fragmentsthereof, such as immunoglobulins; antibodies (monoclonal andpolyclonal); cytokines (e.g., lymphokines, monokines, chemokines); bloodclotting factors; hemopoietic factors; interleukins (IL-2, IL-3, IL-4,IL-6); interferons (β-IFN, α-IFN and γ-IFN); erythropoietin; nucleases;tumor necrosis factor; colony stimulating factors (e.g., GCSF, GM-CSF,MCSF); insulin; anti-tumor agents and tumor suppressors; blood proteins;gonadotropins (e.g., FSH, LH, CG, etc.); hormones and hormone analogs(e.g., growth hormone); vaccines (e.g., tumoral, bacterial and viralantigens); somatostatin; antigens; blood coagulation factors; growthfactors; protein inhibitors; protein antagonists and protein agonists;nucleic acids, such as antisense molecules, DNA, RNA, oligonucleotides,polynucleotides and ribozymes and combinations thereof.

In some embodiments, additives such as image-enhancing agents (e.g.,contrast agents) and more specifically, radiopaque markers, may beincorporated into the medical device. These image-enhancing agentsenable visualization of the wound closure device (against surroundingtissue), when imaged or scanned through different filters such as MRI,X-ray, fluoroscopy, CT, various light sources, and the like. In order tobe opaque (and visualized in certain filters), the wound closure devicemay be made from a material possessing radiographic density higher thanthe surrounding host tissue and have sufficient thickness to affect thetransmission of x-rays to produce contrast in the image. Usefulimage-enhancing agents include but are not limited to radiopaque markerssuch as tantalum, barium sulfate, bismuth trioxide, bromine, iodide,titanium oxide, zirconium, barium, titanium, bismuth, iodine, nickel,iron, silver, and combinations thereof. In some embodiments, compoundssuch as tantalum, platinum, barium and bismuth may be incorporated intothe wound closure device. Often image-enhancing agents are notbioabsorbable or degradable but are excreted from the body or stored inthe body.

Image-enhancing agents may be compounded into the materials (e.g.,resin) as filler prior to processing including extrusion or molding.These agents may be added in various concentrations to maximize polymerprocessing while maximizing the material characteristics of the woundclosure device. The biocompatible agents can be added in quantitiessufficient to enhance radiopacity while maintaining the polymer'sproperties. In certain embodiments, image-enhancing agents may beincorporated into a biodegradable material, enabling surgeons to knowwhen the biodegradable material has degraded.

Methods for combining the above mentioned bioactive agents withmaterials of the present disclosure are within the purview of thoseskilled in the art and include, but are not limited to mixing, blending,compounding, spraying, wicking, solvent evaporating, dipping, brushing,vapor deposition, coextrusion, capillary wicking, film casting, moldingand the like. Additionally, solvents may be used to incorporate variousagents (e.g., bioactive agents) into the composite device. Suitablesolvents include alcohols, e.g., methanol, ethanol, propanol,chlorinated hydrocarbons (such as methylene chloride, chloroform,1,2-dichloro-ethane), and aliphatic hydrocarbons such as hexane,heptene, ethyl acetate.

The above description contains many specifics; these specifics shouldnot be construed as limitations on the scope of the disclosure hereinbut merely as exemplifications of particularly useful embodimentsthereof. Those skilled in the art will envision many other possibilitieswithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

What is claimed is:
 1. A method of closing tissue, the methodcomprising: inserting a medical device through a tissue wall, themedical device having an elongate body including barbs extending from asurface thereof, a foam structure secured to a distal end of theelongate body, and an outer member disposed on the elongate body distalto a proximal end of the elongate body and moveably positionedtherealong such that the medical device is inserted through the tissuewall with the elongate body, the foam structure, and the outer memberall connected together, the outer member and the foam structure eachhaving a proximal portion tapering towards a distal portion; positioningthe medical device in the tissue wall such that the proximal portion ofthe foam structure is adjacent to an inner surface of the tissue wall;and advancing the outer member of the medical device distally over thebarbs of the elongate body and penetrating the tissue wall with thedistal portion of the outer member so as to secure the medical device insitu.
 2. The method of claim 1, wherein the foam structure of themedical device includes a flat surface, and wherein positioning themedical device includes positioning the flat surface of the foamstructure against the inner surface of the tissue wall.
 3. The method ofclaim 1, wherein inserting the medical device includes inserting thefoam structure of the medical device at an angle with respect to theelongate body.
 4. The method of claim 3, wherein positioning the medicaldevice includes turning the foam structure into position against theinner surface of the tissue wall.
 5. The method of claim 3, whereininserting the foam structure includes inserting the foam structuredirectly through the tissue wall without the use of an insertion device.6. The method of claim 1, wherein advancing the outer member includespositioning the outer member adjacent an outer surface of the tissuewall.
 7. The method of claim 1, wherein advancing the outer memberincludes positioning the proximal portion of the outer member against anouter surface of the tissue wall.
 8. A method of closing tissue, themethod comprising: inserting a medical device through a tissue wall, themedical device including an elongate body having an outer membermoveably positioned on the elongate body and a foam structure disposedat a distal end of the elongate body, the outer member and the foamstructure each having a proximal portion tapering towards a distalportion, and the outer member, the foam structure, and at least aportion of the elongate body contained within a sleeve; removing thesleeve such that the foam structure at the distal end of the medicaldevice is positioned adjacent an inner surface of the tissue wall; andadvancing the outer member of the medical device distally over barbs ona surface of the elongate body and penetrating the tissue wall with thedistal portion of the outer member so as to secure the medical device insitu.
 9. The method of claim 8, wherein the foam structure of themedical device includes a flat surface, and wherein removing the sleeveincludes positioning the flat surface of the foam structure against theinner surface of the tissue wall.
 10. The method of claim 8, wherein thefoam structure is contained within the sleeve in a compressed shape, andwherein removing the sleeve includes expanding the foam structure to anexpanded shape.
 11. The method of claim 8, wherein the outer member iscontained within the sleeve in a compressed shape, and wherein removingthe sleeve includes expanding the outer member to an expanded shape. 12.The method of claim 2, wherein advancing the outer member includespositioning the outer member adjacent an outer surface of the tissuewall.
 13. The method of claim 8, wherein advancing the outer memberincludes positioning the proximal portion of the outer member against anouter surface of the tissue wall.